Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10

Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10: Pilot Proof-of-concept, Crossover, Exploratory, Randomized, Double-blind, Placebo-controlled Study

This is a pilot, proof-of-concept, exploratory, randomized, double-blind, placebo-controlled crossover study. The study will be conducted in 50 healthy volunteers with a body mass index (BMI) between 18.5 and 29.9 kg/m². The objective is to comprehensively evaluate the potential of DNF-10 to modulate appetite through the regulation of enteroendocrine hormones and to determine its relevance in human physiology.

Inclusion Criteria:

• Healthy men and women aged 20 to 50 years.

• Body Mass Index (BMI) of 18.5-24.9 kg/m² or 25.0-29.9 kg/m².

• Stable use of permitted medications and/or dietary supplements during the study.

• Individuals willing to maintain their usual dietary and physical activity habits throughout the study.

• Subjects capable of understanding and complying with the study procedures.

• Subjects who have signed the informed consent form.

• Female participants must meet one of the following conditions:

  1. Women with no potential for pregnancy, defined as women who have undergone surgical sterilization or who are postmenopausal.
  2. Women of childbearing potential who use a highly effective contraceptive method (hormonal contraception, intrauterine device, condoms, male partner sterilization [vasectomy], or complete sexual abstinence) while participating in the study.

Exclusion Criteria:

• Individuals with known eating behavior disorders (verified using the Spanish version of the Adult Eating Behavior Questionnaire, AEBQ).
• Subjects with a body weight gain or loss ≥10% within the previous 3 months.
• Treatment with medications or dietary supplements for weight loss, satiety, or glucose control.
• Individuals consuming protein powders or dietary supplements related to the objectives of the study.
• Participants receiving active treatment with GLP-1 receptor agonists or similar agents.
• Participants taking medications or dietary supplements that, in the investigator's opinion, may interfere with the study objectives (e.g., affecting appetite), pose a safety risk, or confound the interpretation of the study results.
• Depression or anxiety disorders that affect appetite.
• High coffee consumption (more than 4 cups per day).
• Smokers (more than 5 cigarettes per week), smoking during study assessment days, and/or drug abuse.
• History of bariatric surgery within the last 3 years.
• Low iron levels requiring treatment.
• Individuals with renal or endocrine diseases (including diabetes).
• Untreated or unstable hyperthyroidism, suicidal ideation, bipolar disorder, or evidence of any untreated or unstable neurological disorder.
• Conditions or diseases that, in the investigator's judgment, may be worsened by participation in the study or may jeopardize the conduct of the study.
• Presence of infectious diseases at the time of study inclusion (participants may be included 1 month after resolution of the illness).
• Severely immunocompromised participants (transplant recipients, individuals treated with anti-rejection medications or steroids within the previous 30 days, or those who have received chemotherapy or radiotherapy within the last year).
• Presence of active malignancy or any concomitant end-stage organ disease within the last 12 months that, in the investigator's judgment, contraindicates participation in the study.
• Hypersensitivity, allergy, or intolerance to any of the components of the study product or standardized study menus (e.g., cow's milk protein allergy [CMPA], celiac disease, or non-celiac gluten intolerance).
• Current participation or participation in another clinical trial within the previous three months.
• Pregnant or breastfeeding women, women seeking pregnancy, or women of childbearing potential who are unwilling to use an effective contraceptive method.